Coblation EIC5872-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 00817470003185), received between Dec 4, 2017 and Jun 16, 2026 — classified as 30 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Break” (58 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING ADENOIDECTOMY, POSTERIOR NASAL PACKING, AND UVULOPALATOPHARY, THE CHILD SUSTAINED A BURN ON THE CORNER OF THE MOUTH. SUBSEQUENTLY, A CONSULTATION WITH THE PLASTIC SURGERY DEPARTMENT WAS REQUESTED, AND DEBRIDEMENT AND SUTURING OF THE LIP WERE PERFORMED. THE CHILD'S RECOVERY PROGRESS REQUIRES ONGOING MONITORING. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP; HOWEVER IT WAS UNKNOWN IT THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 25519583 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT DURING A TONSILLECTOMY PROCEDURE, THE EVAC 70 XTRA COBLATOR IL'S METAL THREADS HAVE BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242486 ↗
• MalfunctionApr 27, 2026Fracture

  IT WAS REPORTED THAT, DURING A SURGERY, THE ELECTRODE OF FOUR EVAC 70 XTRAS WERE FRACTURED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008331 ↗
• MalfunctionApr 19, 2026Fracture

  IT WAS REPORTED THAT, DURING A SURGERY, THE ELECTRODE OF THE EVAC 70 XTRA WAS FRACTURED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921190 ↗
• MalfunctionMar 2, 2026Fracture

  IT WAS REPORTED THAT THE ELECTRODE OF AN EVAC 70 XTRA WAND WAS FRACTURED. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480022 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE ELECTRODE OF AN EVAC 70 XTRA COBLATOR II WAS FRACTURED. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK UP. IT IS UNKNOWN IF THERE WAS A DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480008 ↗
• MalfunctionFeb 19, 2026Fracture

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE ELECTRODE OF THE EVAC 70 WAND WAS FRACTURED. THE SURGERY WAS COMPLETED USING AN EQUIVALENT S&N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389524 ↗
• MalfunctionFeb 19, 2026Fracture

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE ELECTRODE OF THE EVAC 70 WAND WAS FRACTURED. THE SURGERY WAS COMPLETED USING AN EQUIVALENT S&N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389388 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT THE ELECTRODE OF TWO EVAC 70 XTRA WERE BROKEN. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT SN BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264861 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT THE ELECTRODE OF THE EVAC 70 XTRA WAS BROKEN. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264794 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT THE ELECTRODE OF THREE (3) EVAC 70 XTRA WAS BROKEN. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT SN BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235795 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT THE ELECTRODE OF THE EVAC 70 XTRA WAS BROKEN. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT SN BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235734 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE ELECTRODE OF THE EVAC COBLATOR WAND WAS BROKEN. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235643 ↗
• MalfunctionSep 29, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENT SURGERY, THE METAL WIRE OF AN EVAC 70 XTRA WAND BROKE; THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23164280 ↗
• MalfunctionSep 28, 2025Break; Material Erosion; Break; Material Erosion

  IT WAS REPORTED THAT, DURING AN ENT SURGERY, IT WAS NOTICED THAT THE METAL WIRE OF AN EVAC 70 XTRA WAND BROKE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23164087 ↗
• MalfunctionSep 22, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, IT WAS NOTICED THAT THE METAL WIRE OF THE WAND BROKE AND COULD NOT CONTINUE THE OPERATION. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23108070 ↗
• MalfunctionSep 20, 2025Break; Material Erosion; Break; Material Erosion

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, THE METAL WIRE OF THE EVAC WAND BROKE. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23104252 ↗
• MalfunctionSep 20, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, THE METAL WIRE OF THE EVAC WAND BROKE. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23104248 ↗
• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, IT WAS NOTICED THAT THE METAL WIRE OF THE WAND BROKE AND COULD NOT CONTINUE THE OPERATION. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096923 ↗
• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, IT WAS NOTICED THAT THE METAL WIRE OF THE WAND BROKE AND COULD NOT CONTINUE THE OPERATION. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096863 ↗
• MalfunctionSep 8, 2025Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE ELECTRONIC WIRE OF TWO (2) EVAC 70 XTRA COBLATOR WANDS WAS FRACTURED. IT IS UNKNOWN AT WHAT POINT DURING THE PROCEDURE THE EVENT OCCURRED AND IF THERE WAS SURGICAL DELAY. THERE WAS A BACK UP DEVICE AVAILABLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992295 ↗
• MalfunctionSep 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE METAL WIRE OF THE EVAC 70 XTRA COBLATOR WAND BROKE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED WITH A SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963334 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE METAL WIRE OF THE EVAC 70 XTRA COBLATOR BROKE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED WITH A SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955019 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE METAL WIRE OF FOUR (4) EVAC 70 XTRA COBLATOR BROKE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED WITH A SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954655 ↗
• MalfunctionJul 13, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, DURING A TONSILLECTOMY, THE EVAC 70 XTRA WAND'S ELECTRODE BEGAN TO CLOG. THE SURGEON TRIED TO CLEAN IT WITH A COMPRESS, BUT IT WAS SO HOT THAT IT BURNED THE COMPRESS. THE GENERATOR SETTINGS WERE IRRIGATION 3, ABLATION 7 AND HEMOSTASIS 3. THERE WAS NO HARM TO THE PATIENT. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491220 ↗